Thesis (M.S.)--University of Michigan, 1994. / Includes bibliographical references.

The implantable cardioverter defibrillator (ICD) is a small medical device, implanted underneath the collarbone with wires leading from it to the heart. The device detects and terminates ventricular arrhythmias by delivering an electric shock, that otherwise would most likely lead to sudden cardiac arrest and sudden cardiac death. The ICD is perceived as the 'gold standard' treatment therapy for patients at risk of sudden cardiac death resulting from fast electrical rhythms (Bleasdale, Ruskin, O'Callaghan, 2005). However, ICD recipients have reported high levels of psychological distress such as anxiety and depression and a reduced quality of life (e.g. clinical review by Sears, Matchett & Conti, 2009). This thesis describes the development of a brief psychological intervention for patients living with an ICD based on the Medical Research Council's (2008) guidelines. The first stage in the development of the intervention was a qualitative study. Thirtysix ICD participants (ICD patients and partner) were recruited in south Wales. Semistructured interviews were conducted with each participant separately. Thirteen of the patients had not experienced an ICD shock. Transcripts were analysed by thematic analysis (Braun and Clarke, 2006) using a cognitive-emotional-coping framework. General findings revealed patients did not know how to regain normality after their ICD and highlighted common worries were identified. Accordingly, the intervention aimed to be a structured guide underpinned by cognitive behavioural theory. It aimed to address common worries and bridge the gap between hospital discharge and patient's 6-week follow up appointment. The intervention was tested using a pilot randomised control trial. Ninety-nine participants were randomised to an intervention or control group. Differences between groups at baseline were adjusted by analysis of covariance (ANCOVA) to control for differences at 3- and 6-months. Results revealed the intervention group reported improved levels of depression, increased levels of mild exercise and increased patient acceptance to the ICD compared to the control group at 6-months. The simplicity and cost-effectiveness of this intervention suggests that not only is it theory and evidenced based, but should be sustainable long term. The next stage would be to carry out a fully powered randomised control trial.

Encounters in which shared decision-making occur relies on patients and healthcare professionals establishing a partnership. Yet, little is known about the therapeutic relationship (TR) specifically for the implementation and use of patient decision aids (PDA) to facilitate shared decision-making. The aim of this thesis was to explore how the TR is considered when planning PDA implementation for patients eligible for or with an implantable cardioverter-defibrillator (ICD). Using Thorne's interpretive description approach, I conducted a secondary thematic analysis using transcripts with 17 healthcare professionals, ten patients and three family members. Findings were mapped to the TR elements. I identified three themes. First, Pieces of the puzzle: Elements of the TR revealed that while respect and therapeutic communication were identified as important for PDA implementation, other TR were either referred to implicitly or not at all. Second, Good intentions and challenges of establishing a TR revealed that healthcare professionals wanted to engage in TR but lacked time and felt discomfort navigating ICD decisions. Finally, in PDA as support for the TR, participants considered PDAs as being able to facilitate TR elements such as communication and respect, enhancing the consultation. In conclusion, there is a role for TR elements when planning PDA implementation. Further research is needed to explore the other therapeutic relationship elements of genuineness, manifesting a presence, active listening, and reciprocity.

L' Imagerie médicale par Résonance Magnétique (IRM) constitue un outil puissant pour le diagnostic et le suivi de pathologies dans le cadre des modèles développés sur petit animal en neurosciences. Cette application requiert une haute résolution spatiale et un Rapport Signal à Bruit(RSB) élevé, rendus possibles par l’utilisation d’un haut champ magnétique (7 T) et d’une antenne miniature à forte sensibilité, implantée à proximité de la zone d’intérêt. Le design monolithique de l’antenne, appelé Résonateur Multi-tours à Lignes de Transmission (RMLT), permet la miniaturisation en dessous du centimètre et sa réalisation par les technologies de microfabrication en salle blanche.Afin de réduire l’aspect invasif de l’implantation, l’antenne a été réalisée sur support souple :FEP Téflon® ou PDMS. Pour résoudre les problèmes d’adhérence liés à ces matériaux polymères, des traitements plasmas spécifiques ont été mis en œuvre pour le FEP Téflon® tandis qu’un procédé de transfert de motifs dédié au PDMS a été élaboré. Outre la fiabilité mécanique, l’épaisseur du revêtement PDMS assurant la bio compatibilité de l’antenne a été optimisée pour limiter le couplage diélectrique avec les tissus et ainsi conserver des caractéristiques électromagnétiques appropriées à l’IRM à 7 T lorsque l’antenne est implantée. L’ensemble de ces travaux a permis la réalisation des premières images du cerveau du rat acquises in vivo avec une micro-antenne souple implantée. Ces images ont démontré un RSB amélioré d’un facteur 5, comparées à celles acquises avec une antenne commerciale quadrature. D’autres applications et perspectives dans le domaine biomédical sont ouvertes par ces travaux comme des capteurs pour la détermination des propriétés diélectriques des tissus, et des microbobines et des capteurs de pression intégrés dans les canaux microfluidiques. / Magnetic Resonance Imaging (MRI) is a powerful tool for the diagnosis and the monitoring of diseases in the frame of research models developed on small animal in neurosciences. This application requires a high spatial resolution and a high Signal to Noise Ratio (SNR) using a high magnetic field (7 T) and a highly sensitive miniaturized coil, implanted near the interest area. The coilmonolithic design, called Multi-turn Transmission Lines Resonator (MTLR), allows theminiaturization below the centimeter scale and the clean-room technology. To reduce the invasive aspect of implantation, the coil was fabricated on a flexible substrate: FEP Teflon® or PDMS. To overcome adhesion issues related to these polymers, specific plasma treatments were applied to FEPTeflon® while a transfer process dedicated to PDMS was developed. Besides mechanical reliability, the thickness of the PDMS coating ensuring the coil biocompatibility, was optimized to limit the dielectric coupling with tissues and thus to keep suitable electromagnetic characteristics for 7 T MRI when the coil is implanted. This work allowed the achievement of the first images of the rat brain acquired in vivo using an implanted soft coil. These images have shown a 5-fold enhanced SNRcompared with the ones acquired using a commercial quadrature coil. Other applications in the biomedical field are open by this work: sensors for the dielectric characterization of tissues, integrated microcoils and pressure sensors in microfluidic channels.

The effect of CRT on incidence of AF development in patients with severe HF was explored by comparing 36 patients with conventional indication for the CRT to 36 HF patients without CRT, matched for age, sex and LV systolic function (Publication 5). After a follow up of 3 years, the annual incidence of AF in the CRT group was 2.8%, which was significantly lower than the control group (10.2%). Moreover, the echocardiographic benefit by CRT was compared between these 36 patients with SR and 15 patients with persistent AF. The results showed that the echocardiographic response was similar between the two groups. These findings suggested that CRT may have the potential to reduce AF burden in patients with severe HF and that patients with persistent AF may also benefit from CRT. / The objective of the study (Publication 1) was to assess the feasibility of using non-contact LV mapping to delineate the LV endocardial activation pattern in 7 HF patients in NYHA class III, with low LVEF and wide QRS complex (>120ms). Non-contact mapping was safely performed and there were two endocardial conduction patterns identified, namely homogenous (Type I) and conduction block (Type II). The second part of the study (Publication 2) was to determine the implication of these two distinct activation patterns to echocardiographic and clinical response to CRT. 23 patients in NYHA class III, with LVEF <35% and QRS duration >120ms were recruited in this study. 15 patients had Type II pattern and 8 Type I. The QRS duration between the two types of conduction patterns were comparable. Patients with Type II pattern had a more favourable echocardiographic and clinical response to CRT than those with Type I. It was concluded that, despite the similar QRS duration between the two types of LV endocardial activation patterns, patients with Type II pattern had a more favourable response to CRT. / The significance of baseline renal function in CRT was assessed in 85 consecutive patients with conventional indication for the CRT (Publication 7). There was no significant relationship between baseline renal function and significant LV reverse remodeling after CRT, suggesting baseline renal insufficiency probably would not affect the response to CRT. (Abstract shortened by UMI.) / This study (Publication 3) was to determine the effect of CRT in patients with narrow QRS complex and evidence of mechanical dyssynchrony as determined by TDI. 51 patients in NYHA class III or IV, with LV ejection fraction <35%, and QRS duration <120ms were recruited for the CRT. The effect of the device therapy on LV systolic function in this cohort was compared to 51 patients who fulfilled the current criteria with wide QRS complex. CRT significantly improved the LV systolic function, NYHA class and exercise capacity in those with narrow complex to a similar extent in those with wide complex. With co-existing mechanical dyssynchrony determined by TDI, patients in both narrow and wide QRS complex groups showed more favourable response to CRT than those without significant mechanical dyssynchrony. This confirmed that QRS was a poor marker of mechanical dyssynchrony and the current selection criteria are probably not adequate to include more potential responders to the therapy. / This study (Publication 4) was to determine the role of optimal medical therapy in CRT recipients before implantation. The echocardiographic and clinical effect of CRT in 30 patients without the optimal combination of ACEi or ARB and beta-blockers was compared to 30 patients matched for age, sex, NYHA class and HF etiology. Patients with optimal medical therapy had significantly better echocardiographic and clinical response to CRT. The results confirmed that optimal medical therapy is necessary to achieve maximal response by CRT. / This study (Publication 6) was to determine if patients with moderate LV systolic function and wide QRS complex would benefit from the CRT. Significant improvement in LV systolic function was observed in 15 patients with LVEF between 35 and 45%, NYHA class III and QRS duration >120ms after CRT, suggesting that presence of LV systolic dysfunction and cardiac dyssynchrony may be the major determining factors for favourable CRT response. Therefore, patients with less advanced HF may also benefit from the CRT. / "May 2007." / Adviser: Yu Cheuk Man. / Source: Dissertation Abstracts International, Volume: 69-08, Section: B, page: 4657. / Thesis (M.D.)--Chinese University of Hong Kong, 2007. / Includes bibliographical references (p. 133-151). / Electronic reproduction. Hong Kong : Chinese University of Hong Kong, [2012] System requirements: Adobe Acrobat Reader. Available via World Wide Web. / Electronic reproduction. [Ann Arbor, MI] : ProQuest Information and Learning, [200-] System requirements: Adobe Acrobat Reader. Available via World Wide Web. / School code: 1307.

Syftet med denna litteraturöversikt var att beskriva den hälsorelaterade livskvaliteten hos patienter med en implantable cardioverter defibrillator (ICD).  Studien genomfördes som en litteraturöversikt, där tolv vetenskapliga artiklar av kvantitativ karaktär analyserades och användes i studiens resultatdel.  Sökorden som användes var Defibrillators, Implantable, Quality of Life och health related. Inklusionskriterier var artiklar skrivna på engelska, peer-reviewed, publicerade från år 2000 och framåt samt deltagarna i dessa studier skulle vara 19 år eller äldre. I studien framkom det att ICD-patienter undvek specifika platser, objekt och fysiska aktiviteter relaterade till ICD:n. Också en oro över bilkörning framkom.  ICD-patienter utsätts för en förändring i livssituation och är i behov av stöd och individuell informationsgivning gällande deras medicintekniska anordning. Idag är största delen av forskning gjord på män, då implantationsfrekvensen är högre hos dessa. Vidare forskning är relevant och bör omfatta kvinnor, för att på så sätt kunna anpassa framtida vårdinsatser på ett individuellt plan. Vårdgivare behöver fördjupad kunskap inom detta område, då implantationsfrekvensen av ICD är ökande. Kunskap hos vårdgivare kan möjligtvis leda till en ökad hälsorelaterad livskvalitet inom denna patientgrupp. / The aim with this literature study was to describe the health related quality of life in patients with an implantable cardioverter defibrillator (ICD). The study was carried out as a literature study and twelve articles, which all were of quantitative character, were analyzed and constituted the result of the study. The search words that were used were Defibrillators, Implantable, Quality of Life and health related. The criteria of inclusion were articles in English, peer-reviewed, published in 2000 to present day and the participants in these studies had to be 19 years or elder. In the study it emerged that ICD-patients avoided specific places, objects and physical activities related to the ICD. Also a concern regarding driving appeared. ICD-patients are subjects of a change in their life situation and are in need of support and individual information regarding their medicine technical device. To this date, the majority of researches are conducted on men, because of the higher implant frequency within this gender. Further researches are of importance and shall enclose the female gender, to be able to adapt the contribution of nursing on an individual level. Health care providers are in need of deepened knowledge within this area, because of the rising frequency of implantation. This knowledge might lead to a increased health related quality of life within this patient group.

<p>Syftet med denna litteraturöversikt var att beskriva den hälsorelaterade livskvaliteten hos patienter med en implantable cardioverter defibrillator (ICD).  Studien genomfördes som en litteraturöversikt, där tolv vetenskapliga artiklar av kvantitativ karaktär analyserades och användes i studiens resultatdel.  Sökorden som användes var <em>Defibrillators, Implantable, Quality of Life </em>och<em> health related. </em>Inklusionskriterier var artiklar skrivna på engelska, peer-reviewed, publicerade från år 2000 och framåt samt deltagarna i dessa studier skulle vara 19 år eller äldre. I studien framkom det att ICD-patienter undvek specifika platser, objekt och fysiska aktiviteter relaterade till ICD:n. Också en oro över bilkörning framkom.  ICD-patienter utsätts för en förändring i livssituation och är i behov av stöd och individuell informationsgivning gällande deras medicintekniska anordning. Idag är största delen av forskning gjord på män, då implantationsfrekvensen är högre hos dessa. Vidare forskning är relevant och bör omfatta kvinnor, för att på så sätt kunna anpassa framtida vårdinsatser på ett individuellt plan. Vårdgivare behöver fördjupad kunskap inom detta område, då implantationsfrekvensen av ICD är ökande. Kunskap hos vårdgivare kan möjligtvis leda till en ökad hälsorelaterad livskvalitet inom denna patientgrupp.</p> / <p>The aim with this literature study was to describe the health related quality of life in patients with an implantable cardioverter defibrillator (ICD). The study was carried out as a literature study and twelve articles, which all were of quantitative character, were analyzed and constituted the result of the study. The search words that were used were <em>Defibrillators, Implantable, Quality of Life </em>and<em> health related. </em>The criteria of inclusion were articles in English, peer-reviewed, published in 2000 to present day and the participants in these studies had to be 19 years or elder. In the study it emerged that ICD-patients avoided specific places, objects and physical activities related to the ICD. Also a concern regarding driving appeared. ICD-patients are subjects of a change in their life situation and are in need of support and individual information regarding their medicine technical device. To this date, the majority of researches are conducted on men, because of the higher implant frequency within this gender. Further researches are of importance and shall enclose the female gender, to be able to adapt the contribution of nursing on an individual level. Health care providers are in need of deepened knowledge within this area, because of the rising frequency of implantation. This knowledge might lead to a increased health related quality of life within this patient group.</p>

This dissertation presents the system architecture and implementation of two wireless systems-on-chip (SoCs) for diagnostics and treatment of neurological disorders. It also validates the SoCs as an electronic implant for preoperative monitoring and treatment of intractable epilepsy. The first prototype SoC is a neural recording interface intended for wireless monitoring of intractable epilepsy. The 0.13um CMOS SoC has 64 recording channels, 64 programmable FIR filters and an integrated 915MHz FSK PLL-based wireless transmitter. Each channel contains a low-noise amplifier and a modified 8-bit SAR ADC that and can provide analog-digital multiplication by modifying the ADC sampling phase. It is used in conjunction with 12-bit digital adders and registers to implement 64 16-tap FIR filters with a minimal area and power overhead. In vivo measurement results from freely moving rodents demonstrate its utility in preoperative monitoring epileptic seizures. Treatment of intractable epilepsy by responsive neurostimulation requires seizure detection capabilities. Next, a low-power VLSI processor architecture for early seizure detection is described. It the magnitude, phase and phase synchronization of two neural signals - all precursors of a seizure. The processor is utilized in an implantable responsive neural stimulator application. The architecture uses three CORDIC processing cores that require shift-and-add operations but no multiplication. The efficacy of the processor in epileptic seizure detection is validated on human EEG data and yields comparable performance to software-based algorithms. The second prototype SoC is a closed-loop 64-channel neural stimulator that includes the aforementioned seizure detector processor and is used for preventive seizure abortion. It constitutes a neural vector analyzer that monitors the magnitude, phase and phase synchronization of neural signals to enable seizure detection. In a closed loop, abnormal phase synchrony triggers the programmable-waveform biphasic neural stimulator. To implement these functionalities, the 0.13um CMOS SoC integrates 64 amplifiers with switched-capacitor (SC) bandpass filters, 64 MADCs, 64 16-tap FIR filters, a processor, 64 biphasic stimulators and a wireless transmitter. The SoC is validated in the detection and abortion of seizures in freely moving rodents on-line and in early seizure detection in humans off-line. The results demonstrate its utility in treatment of intractable epilepsy.

This dissertation presents the system architecture and implementation of two wireless systems-on-chip (SoCs) for diagnostics and treatment of neurological disorders. It also validates the SoCs as an electronic implant for preoperative monitoring and treatment of intractable epilepsy. The first prototype SoC is a neural recording interface intended for wireless monitoring of intractable epilepsy. The 0.13um CMOS SoC has 64 recording channels, 64 programmable FIR filters and an integrated 915MHz FSK PLL-based wireless transmitter. Each channel contains a low-noise amplifier and a modified 8-bit SAR ADC that and can provide analog-digital multiplication by modifying the ADC sampling phase. It is used in conjunction with 12-bit digital adders and registers to implement 64 16-tap FIR filters with a minimal area and power overhead. In vivo measurement results from freely moving rodents demonstrate its utility in preoperative monitoring epileptic seizures. Treatment of intractable epilepsy by responsive neurostimulation requires seizure detection capabilities. Next, a low-power VLSI processor architecture for early seizure detection is described. It the magnitude, phase and phase synchronization of two neural signals - all precursors of a seizure. The processor is utilized in an implantable responsive neural stimulator application. The architecture uses three CORDIC processing cores that require shift-and-add operations but no multiplication. The efficacy of the processor in epileptic seizure detection is validated on human EEG data and yields comparable performance to software-based algorithms. The second prototype SoC is a closed-loop 64-channel neural stimulator that includes the aforementioned seizure detector processor and is used for preventive seizure abortion. It constitutes a neural vector analyzer that monitors the magnitude, phase and phase synchronization of neural signals to enable seizure detection. In a closed loop, abnormal phase synchrony triggers the programmable-waveform biphasic neural stimulator. To implement these functionalities, the 0.13um CMOS SoC integrates 64 amplifiers with switched-capacitor (SC) bandpass filters, 64 MADCs, 64 16-tap FIR filters, a processor, 64 biphasic stimulators and a wireless transmitter. The SoC is validated in the detection and abortion of seizures in freely moving rodents on-line and in early seizure detection in humans off-line. The results demonstrate its utility in treatment of intractable epilepsy.

The goal of this thesis was to evaluate the cost-effectiveness of implantable Doppler technology (IDT) used to monitor free tissue transfer (FTT) procedures in the treatment of cancer of the upper aerodigestive tract (UADT). First, a systematic review of the literature on the effectiveness of traditional and IDT monitoring techniques was performed. Second, a utility survey using a time trade-off technique was created and administered. The results from this survey were used to establish utility values for health states common in patients undergoing FTT procedures. Third, a cost study using the microcosting data available through the Ottawa Hospital was performed. Finally, a decision analytic model was created and an economic evaluation from the payer perspective was completed. A probabilistic sensitivity analysis (PSA) and a value of information analysis (VOI) were performed. The thesis found that the currently available evidence supports IDT as a cost-effective intervention. Further research should be directed towards determining the effectiveness of both traditional and IDT monitoring.